DFS ADULT RAIL 06316

GUDID 00887868083730

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00887868083730
• NIH Device Record Key: 29126040-16d5-43ea-b78e-27e3a9dd9f5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS ADULT RAIL
• Version Model Number: 06316
• Catalog Number: 06316
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868083730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021031

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

[00887868083730]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [DFS ADULT RAIL]

• 00888480111344: 06105
• 00888480111290: 06085
• 00888480111252: 06070
• 00888480111160: 06046
• 00888480111108: 06020
• 00887868083907: 06420
• 00887868083891: 06411
• 00887868083884: 06410
• 00887868083877: 06400
• 00887868083860: 06395
• 00887868083853: 06390
• 00887868083846: 06385
• 00887868083839: 06380
• 00887868083822: 06376
• 00887868083815: 06375
• 00887868083808: 06370
• 00887868083792: 06360
• 00887868083785: 06350
• 00887868083778: 06345
• 00887868083761: 06342
• 00887868083754: 06330
• 00887868083747: 06320
• 00887868083730: 06316
• 00887868083723: 06315
• 00887868083716: 06311
• 00887868083709: 06310
• 00887868083693: 06306
• 00887868083686: 06305
• 00887868083679: 06301
• 00887868083662: 06300
• 00887868083655: 06262
• 00887868083648: 06260
• 00887868083600: 06255
• 00887868083594: 06250
• 00887868083587: 06248
• 00887868083570: 06240
• 00887868083440: 06140
• 00887868083426: 06115
• 00887868083419: 06110
• 00887868083389: 06075
• 00887868083341: 06058